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Remote Tai Chi for PTSD and Chronic Pain

N/A
Recruiting
Led By Barbara L Niles, PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PTSD Case Definition. Veterans who meet DSM-5 diagnostic criteria according to DSM-5 diagnostic algorithm for current PTSD as assessed on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be eligible for the study. A diagnosis of current PTSD requires: a traumatic stressor (Criterion A) and the requisite number of symptoms at a severity level of 2 or higher in each symptom cluster. Each symptom is rated on a severity scale of 0 (no symptoms) to 4 (extreme), with 2 representing clinically significant and clearly present symptomatology. An individual must endorse at least one reexperiencing (Criterion B) symptom, at least one avoidance (Criterion C) symptom, at least two symptoms of negative alterations in cognition and mood (Criterion D), and at least two hyperarousal (Criterion E) symptoms. In addition, these symptoms must have been present for at least one month (Criterion F) and cause either clinically significant distress or functional impairment (Criterion G).
Chronic pain as indicated by complaints of musculoskeletal pain in one or more body regions for six months or more
Must not have
Lacks the capacity to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up follow-up (about 6 months)
Awards & highlights

Summary

This trial will refine interventions to test the efficacy of Tai Chi vs Wellness to help Veterans with PTSD and chronic pain.

Who is the study for?
This trial is for Veterans with PTSD and chronic musculoskeletal pain lasting over six months, who have internet access for telehealth. They must not start any new evidence-based psychotherapy during the study but can continue if prescribed by a provider. Participants should be able to stand for Tai Chi sessions and attend scheduled intervention times.
What is being tested?
The trial tests two 12-week interventions delivered remotely: Tai Chi versus a Wellness program, to see which helps more with PTSD and chronic pain in Veterans. It's a small-scale randomized trial meant to set up for a larger future study.
What are the potential side effects?
Since this trial involves physical activity (Tai Chi) and wellness programs, side effects may include muscle soreness or strain from exercise. However, these activities are generally low-risk and promote overall well-being.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a veteran diagnosed with PTSD by a professional using the CAPS-5 scale.
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I have had pain in my muscles or bones in one or more areas for over six months.
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I can attend the scheduled group sessions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand or sign a consent form.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~follow-up (about 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and follow-up (about 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Participant adherence with completion of assessments
Participant adherence with intervention group sessions
Participant satisfaction at follow-up with interventions being tested
+1 more
Secondary study objectives
Burden of administration of the Clinician Administered PTSD Scale, 5th Edition (CAPS-5)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tai Chi GroupExperimental Treatment1 Intervention
Participants randomized to this arm will receive a standardized Tai Chi protocol developed for veterans, adapted by the investigators, and administered by experienced VA Tai Chi instructors.
Group II: Wellness GroupActive Control1 Intervention
Participants randomized to this arm will receive a wellness program that has been successfully used by the investigators in other studies of veterans with chronic pain.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tai Chi
2014
Completed Phase 2
~1660

Find a Location

Who is running the clinical trial?

Tufts Medical CenterOTHER
261 Previous Clinical Trials
264,147 Total Patients Enrolled
Boston UniversityLead Sponsor
467 Previous Clinical Trials
9,954,220 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
846 Previous Clinical Trials
672,877 Total Patients Enrolled

Media Library

Tai Chi Clinical Trial Eligibility Overview. Trial Name: NCT05693805 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Tai Chi Group, Wellness Group
Post-Traumatic Stress Disorder Clinical Trial 2023: Tai Chi Highlights & Side Effects. Trial Name: NCT05693805 — N/A
Tai Chi 2023 Treatment Timeline for Medical Study. Trial Name: NCT05693805 — N/A
~23 spots leftby Dec 2025
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